Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty.

This phase 3 trial compared the efficacy and safety of rivaroxaban, an oral direct inhibitor of factor Xa, with those of enoxaparin for extended thromboprophylaxis in patients undergoing total hip arthroplasty.In this randomized, double-blind study, we assigned 4541 patients to receive either 10 mg of oral rivaroxaban once daily, beginning after surgery, or 40 mg of enoxaparin subcutaneously once daily, beginning the evening before surgery, plus a placebo tablet or injection. The primary efficacy outcome was the composite of deep-vein thrombosis (either symptomatic or detected by bilateral venography if the patient was asymptomatic), nonfatal pulmonary embolism, or death from any cause at 36 days (range, 30 to 42). The main secondary efficacy outcome was major venous thromboembolism (proximal deep-vein thrombosis, nonfatal pulmonary embolism, or death from venous thromboembolism). The primary safety outcome was major bleeding.A total of 3153 patients were included in the superiority analysis (after 1388 exclusions), and 4433 were included in the safety analysis (after 108 exclusions). The primary efficacy outcome occurred in 18 of 1595 patients (1.1\%) in the rivaroxaban group and in 58 of 1558 patients (3.7\%) in the enoxaparin group (absolute risk reduction, 2.6\%; 95\% confidence interval [CI], 1.5 to 3.7; P<0.001). Major venous thromboembolism occurred in 4 of 1686 patients (0.2\%) in the rivaroxaban group and in 33 of 1678 patients (2.0\%) in the enoxaparin group (absolute risk reduction, 1.7\%; 95\% CI, 1.0 to 2.5; P<0.001). Major bleeding occurred in 6 of 2209 patients (0.3\%) in the rivaroxaban group and in 2 of 2224 patients (0.1\%) in the enoxaparin group (P=0.18).A once-daily, 10-mg oral dose of rivaroxaban was significantly more effective for extended thromboprophylaxis than a once-daily, 40-mg subcutaneous dose of enoxaparin in patients undergoing elective total hip arthroplasty. The two drugs had similar safety profiles. (ClinicalTrials.gov number, NCT00329628.

Detection of Sentinel Lymph Nodes in patients with Early Stage Cervical Cancer

The purpose of this study was to determine the feasibility of identifying the sentinel lymph nodes (SNs) as well as to evaluate factors that might influence the SN detection rate in patients with cervical cancer of the uterus. Eighty nine patients underwent intracervical injection of 1% isosulfan blue dye at the time of planned radical hysterectomy and lymphadenectomy between January 2003 and December 2003. With the visual detection of lymph nodes that stained blue, SNs were identified and removed separately. Then all patients underwent complete pelvic lymph node dissection and/or para-aortic lymph node dissection. SNs were identified in 51 of 89 (57.3%) patients. The most common site for SN detection was the external iliac area. Metastatic nodes were detected in 21 of 89 (23.5%) patients. One false negative SN was obtained. Successful SN detection was more likely in patients younger than 50 yr (p=0.02) and with a history of preoperative conization (p=0.05). However, stage, histological type, surgical procedure and neoadjuvant chemotherapy showed no significant difference for SN detection rate. Therefore, the identification of SNs with isosulfan blue dye is feasible and safe. The SN detection rate was high in patients younger than 50 yr or with a history of preoperative conization

Relative effect of urinary calcium and oxalate on saturation of calcium oxalate Rapid Communication

Relative effect of urinary calcium and oxalate on saturation of calcium oxalate.BackgroundThe study compared the effect of urinary calcium with that of oxalate on urinary saturation [relative saturation ratio (RSR)] of calcium oxalate.MethodsA retrospective data analysis was conducted on urinary stone risk analysis from 667 patients with predominantly calcium oxalate stones. Urinary RSR of calcium oxalate was individually calculated using Equil 2. A “theoretical” curve of the relationship between urinary RSR of calcium oxalate and concentration of calcium or oxalate was obtained at two stability constants for calcium oxalate complex, while varying calcium or oxalate and using group mean values for urinary constituents.ResultsAt the stability constant of 7.07 × 103, the increase in RSR of calcium oxalate was less marked with calcium than with oxalate. However, at the stability constant of 2.746 × 103 from the Equil 2 that is considered the “gold standard,” calcium and oxalate were equally effective in increasing RSR of calcium oxalate. The above theoretical curves (relating RSR with calcium or oxalate) were closely approximated by the actual curves constructed with data from individual urine samples. Urinary saturation of calcium oxalate was equally dependent on urinary concentrations of calcium and oxalate (r = 0.75 unadjusted and 0.57 adjusted for variables, and P < 0.0001 for calcium; r = 0.73 unadjusted and 0.60 adjusted, P <0.0001 for oxalate).ConclusionAmong calcium oxalate stone-formers, urinary calcium is equally effective as urinary oxalate in increasing RSR of calcium oxalate

The Effects of Integrative In-Patient Treatment on Patients’ Quality of Life: A Meta-Analysis

Background. In the last decades, several hospitals have adopted this concept of integrative medicine for the treatment of chronic and acute states of illnesses in in-patient treatment. The aim of this paper was to summarize the current evidence for a possible effectiveness of integrative on-patient treatment in patients’ quality of life by means of a meta-analysis. Material and Methods. The databases MEDLINE, EMBASE, AMED, PsycInfo, PsycLit CCMED, and CAMbase were screened to find articles. We also screened publisher databases to find relevant information. Articles were included if patients were treated in a hospital. To guarantee comparability SF-36 was the predefined outcome measure for patients’ quality of life. Data of pre/posteffects on the mental and physical scores of the SF-36 were extracted and effect sizes were calculated and entered into a random effect meta-analysis. Results. Eight articles published between 2003 and 2010 were included in the final meta-analysis. Random effect meta-analysis of the eight studies revealed an overall effect size of 0.37 (95% CI: [0.28; 0.45]) in the physical score and 0.38 (95% CI: [0.30; 0.45]) in the mental score of the SF-36. I2 statistics indicate a high heterogeneity in the effects in both the physical and mental scores of the SF-36 (I2 = 91.8%, P<0.001, resp.; I2 = 86.7%, P<0.001). Discussion. This meta-analysis might help to rediscover the importance of integrative in-patient treatment for patients, physicians, and stakeholders

Genetic variant predicts bevacizumab-induced hypertension in ECOG-5103 and ECOG-2100

Background: Bevacizumab has broad anti-tumour activity, but substantial risk of hypertension. No reliable markers are available for predicting bevacizumab-induced hypertension. Methods: A genome-wide association study (GWAS) was performed in the phase III bevacizumab-based adjuvant breast cancer trial, ECOG-5103, to evaluate for an association between genotypes and hypertension. GWAS was conducted in those who had experienced systolic blood pressure (SBP) >160 mm Hg during therapy using binary analysis and a cumulative dose model for the total exposure of bevacizumab. Common toxicity criteria (CTC) grade 3–5 hypertension was also assessed. Candidate SNP validation was performed in the randomised phase III trial, ECOG-2100. Results: When using the phenotype of SBP>160 mm Hg, the most significant association in SV2C (rs6453204) approached and met genome-wide significance in the binary model (P=6.0 × 10−8OR=3.3) and in the cumulative dose model (P=4.7 × 10−8HR=2.2), respectively. Similar associations with rs6453204 were seen for CTC grade 3–5 hypertension but did not meet genome-wide significance. Validation study from ECOG-2100 demonstrated a statistically significant association between this SNP and grade 3/4 hypertension using the binary model (P-value=0.037OR=2.4). Conclusions: A genetic variant in SV2C predicted clinically relevant bevacizumab-induced hypertension in two independent, randomised phase III trials

Systematic review with meta-analysis: the significance of histological disease severity in lean patients with nonalcoholic fatty liver disease

Background: Current evidence suggests that lean and obese patients with nonalcoholic fatty liver disease (NAFLD) share an altered metabolic and cardiovascular profile. However, there is an incomplete understanding of the natural history of “lean-NAFLD.” Indeed, an unanswered question is whether lean (BMI ≤ 25 Kg/m2) NAFLD-patients are protected from severe histological outcomes. Aim: To perform a meta-analysis with the goal of providing a quantitative estimation of the magnitude of fibrosis, as well as histological features associated with the disease severity, in lean versus overweight/obese-NAFLD patients. Methods: Through a systematic search up to July 2017, we identified eight studies that compared histological outcomes in lean (n = 493) versus overweight/obese (n = 2209) patients. Results: Relative to lean-NAFLD, overweight/obese-NAFLD patients showed significantly (P =.032) higher fibrosis scores; the observed difference in means between the two groups, which is the absolute difference between the mean value of fibrosis score [0-4] ± standard error, was 0.28 ± 0.13. The risk of having nonalcoholic steatohepatitis-NASH (OR 0.58 95% CI 0.34-0.97) was significantly lower in lean-NAFLD (n = 322) than in overweight/obese-NAFLD (n = 1357), P =.04. Relative to lean-NAFLD, overweight/obese-NAFLD patients also have significantly greater NAFLD activity (difference in means ± SE: 0.58 ± 0.16, P =.0004) and steatosis (difference in means ± SE: 0.23 ± 0.07, P =.002) scores. Conclusions: Lean-NAFLD patients tend to show less severe histological features as compared to overweight/obese-NAFLD patients. Subsequent longitudinal assessment is needed to understand the clinical impact of these findings; however, the significant ~ 25% increment of mean fibrosis score in overweight/obese patients suggests that obesity could predict a worse long-term prognosis.Fil: Sookoian, Silvia Cristina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto de Investigaciones Médicas. Universidad de Buenos Aires. Facultad de Medicina. Instituto de Investigaciones Médicas; Argentina. Universidad de Buenos Aires. Facultad de Medicina. Instituto de Investigaciones Médicas; ArgentinaFil: Pirola, Carlos José. Universidad de Buenos Aires. Facultad de Medicina. Instituto de Investigaciones Médicas; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto de Investigaciones Médicas. Universidad de Buenos Aires. Facultad de Medicina. Instituto de Investigaciones Médicas; Argentin

Validation of a New Prognostic Score in Patients with Ovarian Adenocarcinoma

Background and Objectives: This study aimed to assess the impact of clinical prognostic factors and propose a prognostic score that aids the clinician’s decision in estimating the risk for patients in clinical practice. Materials and Methods: The study included 195 patients diagnosed with ovarian adenocarcinoma. The therapeutic strategy involved multidisciplinary decisions: surgery followed by adjuvant chemotherapy (80%), neoadjuvant chemotherapy followed by surgery (16.4%), and only chemotherapy in selected cases (3.6%). Results: After a median follow-up of 68 months, in terms of progression-free survival (PFS) and overall survival (OS), Eastern Cooperative Oncology Group (ECOG) performance status of 1 and 2 vs. 0 (hazard ratio—HR = 2.71, 95% confidence interval—CI, 1.96–3.73, p < 0.001 for PFS and HR = 3.19, 95%CI, 2.20–4.64, p < 0.001 for OS), menopausal vs. premenopausal status (HR = 2.02, 95%CI, 1.35–3,0 p < 0.001 and HR = 2.25, 95%CI = 1.41–3.59, p < 0.001), ascites (HR = 1.95, 95%CI 1.35–2.80, p = 0.03, HR = 2.31, 95%CI = 1.52–3.5, p < 0.007), residual disease (HR = 5.12, 95%CI 3.43–7.65, p < 0.0001 and HR = 4.07, 95%CI = 2.59–6.39, p < 0.0001), and thrombocytosis (HR = 2.48 95%CI = 1.72–3.58, p < 0.0001, HR = 3.33, 95%CI = 2.16–5.13, p < 0.0001) were associated with a poor prognosis. An original prognostic score including these characteristics was validated using receiver operating characteristic (ROC) curves (area under the curve—AUC = 0.799 for PFS and AUC = 0.726 for OS, p < 0.001). The median PFS for patients with none, one, two, three, or four (or more) prognostic factors was not reached, 70, 36, 20, and 12 months, respectively. The corresponding median overall survival (OS) was not reached, 108, 77, 60, and 34 months, respectively. Conclusions: Several negative prognostic factors were identified: ECOG performance status ≥ 1, the presence of ascites and residual disease after surgery, thrombocytosis, and menopausal status. These led to the development of an original prognostic score that can be helpful in clinical practice

Effect of β blockers on mortality after myocardial infarction in adults with COPD: Population based cohort study of UK electronic healthcare records

Objectives: To investigate whether the use and timing of prescription of β blockers in patients with chronic obstructive pulmonary disease (COPD) having a first myocardial infarction was associated with survival and to identify factors related to their use. Design: Population based cohort study in England. Setting: UK national registry of myocardial infarction (Myocardial Ischaemia National Audit Project (MINAP)) linked to the General Practice Research Database (GPRD), 2003-11. Participants: Patients with COPD with a first myocardial infarction in 1 January 2003 to 31 December 2008 as recorded in MINAP, who had no previous evidence of myocardial infarction in their GPRD or MINAP record. Data were provided by the Cardiovascular Disease Research using Linked Bespoke studies and Electronic Health Records (CALIBER) group at University College London. Main outcome measure: Cox proportional hazards ratio for mortality after myocardial infarction in patients with COPD in those prescribed β blockers or not, corrected for covariates including age, sex, smoking status, drugs, comorbidities, type of myocardial infarction, and severity of infarct. Results: Among 1063 patients with COPD, treatment with β blockers started during the hospital admission for myocardial infarction was associated with substantial survival benefits (fully adjusted hazard ratio 0.50, 95% confidence interval 0.36 to 0.69; P<0.001; median follow-up time 2.9 years). Patients already taking a β blocker before their myocardial infarction also had a survival benefit (0.59, 0.44 to 0.79; P<0.001). Similar results were obtained with propensity scores as an alternative method to adjust for differences between those prescribed and not prescribed β blockers. With follow-up started from date of discharge from hospital, the effect size was slightly attenuated but there was a similar protective effect of treatment with β blockers started during hospital admission for myocardial infarction (0.64, 0.44 to 0.94; P=0.02). Conclusions: The use of β blockers started either at the time of hospital admission for myocardial infarction or before a myocardial infarction is associated with improved survival after myocardial infarction in patients with COPD. Registration: NCT01335672